This randomized phase I trial studies the side effects of vaccine therapy in preventing cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body build an effective immune response and prevent or delay the recurrence of CMV infection in patients undergoing donor stem cell transplant for hematological malignancies.

Safety based on assessment of GVHD, graded according to the Keystone Consensus system and adverse events (AEs) based on National Cancer Institute (NCI) CTCAE version 4.03 [ Time Frame: Up to day 180 ] [ Designated as safety issue: Yes ]

GVHD, local and systemic reactogenicity, and toxicity related to the vaccine formulation will be evaluated by the study principal investigator (PI), conferring with the treating physician.

Compare levels of CD8 T cells binding to CMV-specific tetramers in vaccinated and unvaccinated HCT recipients by Wilcoxon rank-sum test, using integrated CMV-specific CD8 T cells levels over the first 100 days as a numerical outcome. PD-1 expression and levels of apoptosis markers and proliferation of CMV-specific T cells immune-parameters will be compared in both arms using the Kruskall-Wallis rank-sum test. Mixed models and generalized estimating equations will be used to permit quantitative estimation of potentially interacting covariables.

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

All medications, supportive care, blood products or radiation therapy taken or administered during the trial will be documented in the subject's clinical/hospital and case report form (CRF), using City of Hope (COH) guidelines; the subject's clinical information will be recorded on the appropriate CRF

Concurrent enrollment in other clinical trials using an investigational product is prohibited

The use of alemtuzumab for immunosuppression is not permitted in this study

Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment is not allowed

Medications that might interfere with the evaluation of the investigational product should not be administered, from 30 days prior to participation on the trial and up to 14 days after the second vaccination (day 70 post-HCT); medications in this category include, but are not limited to:

Antiviral treatment for herpes simplex virus (HSV), human herpes virus 6 (HHV6), Epstein-Barr virus (EBV) and adenovirus including the use of GVC/VAL, FOS, Cidofovir, CMX-001 may also suppress reactivation of CMV, thus it will not be allowed in this study; patients requiring such treatment before randomization (day 28) will be removed from the study and replaced; reasons for removal will be reported in the patient's CRF

All enrolled recipients who will require anti-CMV therapy before day 28 will be replaced, treated and monitored as required by COH standard of care; GVC/VAL, FOS, Cidofovir, CMX-001 may be used according to COH standard of care (SOC) for preemptive management of CMV viremia; should antiviral treatment be required after day 28, the planned 2nd vaccine injection at day 56 will not be administered (vaccine arm only)

All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

A poor-risk patient, as defined by any of the following:

Chronic myelogenous leukemia in blast crisis

Acute myeloid leukemia beyond second remission

Multiple myeloma

Aplastic anemia

Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting agent

In vitro T cell depleted graft

Planned prophylactic therapy with CMV immunoglobulin

Planned CMV prophylactic therapy

Experimental anti-CMV chemotherapy in the last 6 months

Diagnosed with autoimmune disease

Receipt of the following substances:

Any prior investigational CMV vaccine

Live attenuated vaccines, medically indicated subunit or killed vaccines from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)

Investigational research products or allergy treatment with antigens injections from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)

Pregnant and/or breast feeding if a female recipient

Refusing to use contraception up to 90 days post-HCT

POST-HCT STUDY-SPECIFIC EXCLUSIONS:

On days 28 and 56 post-HCT (immunization day for the vaccine arm) all study recipients (vaccine and observation arms) will be reviewed for eligibility and ruled ineligible to initiate or continue in the study and receive vaccination (for the vaccine arm) if:

Diagnosed with > grade 2 graft-versus-host disease (GVHD) before day 28 post-HCT, and diagnosed with > grade 2 GVHD between day 28 post-HCT and administration of the 2nd vaccine at day 56

Received steroid therapy with prednisone > 1 mg/kg/day, less than 7 days prior to injection

Had relapse

Experience graft failure (absolute neutrophil count < 500/mm^3)

Received antiviral treatment with GVC/VAL, FOS, Cidofovir, CMX-001 at any point during the 28 day period

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588015